Topamax (Topiramate) Drug Information

Why is this medication prescribed?

Topamax (topiramate) is used alone or with other medications to treat certain types of seizures in people who have epilepsy. Topamax (topiramate) is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topamax (topiramate) is used to treat patients who continue to have seizures even when they take other antiseizure medications. Topamax (topiramate) is also used to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur. Topamax (topiramate) is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.

How should this medicine be used?

Topamax (topiramate) comes as a tablet and a sprinkle capsule (capsule that contains small beads of medication that can be sprinkled on food) to take by mouth. It is usually taken with or without food twice a day in the morning and evening. Take Topamax (topiramate) at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Topamax (topiramate) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

There is another medication with a name similar to the brand name for Topamax (topiramate). You should be sure that you receive Topamax (topiramate) and not the similar medication each time you fill your prescription. Be sure that the prescription your doctor gives you is clear and easy to read. Talk to your pharmacist to be sure that you are given Topamax (topiramate). After you receive your medication, compare the tablets to the pictures in the manufacturer's patient information sheet. If you think you were given the wrong medication, talk to your pharmacist. Do not take any medication unless you are certain it is the medication that your doctor prescribed.

Topamax (topiramate) tablets have a bitter taste so you should swallow them whole. Do not split, chew, or crush them. It is especially important that you not take Topamax (topiramate) tablets that have been broken for any length of time because tablets that are broken may lose their effectiveness over time.

Your doctor will probably start you on a low dose of Topamax (topiramate) and gradually increase your dose, not more than once every week.

Topamax (topiramate) may control your seizures or migraines but will not cure your condition. Continue to take Topamax (topiramate) even if you feel well. Do not stop taking Topamax (topiramate) without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking Topamax (topiramate), you may have severe seizures, even if you have not had seizures in the past. Your doctor will probably decrease your dose gradually.

The sprinkle capsules may be swallowed whole or opened and poured over food. To take the sprinkle capsule with food, follow these steps:

Prepare a teaspoonful of soft food such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt.

Hold the capsule upright over the food. You should be able to read the word 'TOP' on the capsule.

Twist off the clear part of the capsule and pour the entire contents onto the spoonful of food.

Swallow the entire mixture immediately without chewing.

Drink fluids right after swallowing to wash down the mixture and to be sure that you swallow all of it.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with Topamax (topiramate) and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Other uses for this medicine

Topamax (topiramate) is also used for the management of alcohol dependence. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking Topamax (topiramate):

tell your doctor and pharmacist if you are allergic to Topamax (topiramate) or any other medications.

tell your doctor if you or any family members have or have ever had kidney stones, if you drink or have ever drunk large amounts of alcohol, and if you have ever thought about killing yourself or tried to do so. Also tell your doctor if you have or have ever had metabolic acidosis (a disturbance in the body's acid-base balance that results in excessive acidity of the blood); osteopenia, osteomalacia, or osteoporosis (conditions in which the bones are soft or brittle and may break easily); diabetes; glaucoma (a type of eye disease); any disease that affects your breathing such as asthma or chronic obstructive pulmonary disease (COPD); depression or abnormal moods; a growth problem; or liver or kidney disease. Also tell your doctor if you have diarrhea or if you develop diarrhea during your treatment.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you are pregnant or plan to become pregnant, your doctor may prescribe a different medication instead of Topamax (topiramate) because Topamax (topiramate) may harm the fetus. If you do not plan to become pregnant, you should use birth control to prevent pregnancy during your treatment with Topamax (topiramate). Talk to your doctor about what type of birth control you should use, because taking Topamax (topiramate) may decrease the effectiveness of some types of birth control. If you become pregnant while you are taking Topamax (topiramate), call your doctor right away, but do not stop taking Topamax (topiramate) before talking to your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Topamax (topiramate).

you should know that Topamax (topiramate) may make you drowsy, dizzy, confused, or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you.

if you are taking Topamax (topiramate) to control seizures, you should know that you may continue to have seizures during your treatment. You may need to avoid activities such as swimming, driving, and climbing so that you will not harm yourself or others if you lose consciousness during a seizure.

ask your doctor about the safe use of alcoholic beverages while you are taking Topamax (topiramate).

you should know that Topamax (topiramate) can prevent you from sweating and make it harder for your body to cool down when it gets very hot. This happens most often in warm weather and to children who take Topamax (topiramate). Avoid exposure to heat, drink plenty of fluids and tell your doctor if you have a fever, headache, muscle cramps, or an upset stomach, or if you are not sweating as usual.

you should know that you may be more likely to develop a kidney stone while you are taking Topamax (topiramate). Drink 6 to 8 glasses of water every day to prevent kidney stones from forming.

you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking Topamax (topiramate) for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took antiepileptics such as Topamax (topiramate) to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as 1 week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an antiepileptic medication such as Topamax (topiramate), but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an antiepileptic medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What special dietary instructions should I follow?

Talk to your doctor about increasing the amount of food you eat if you lose weight while you are taking Topamax (topiramate).

Talk to your doctor before changing your diet or beginning any type of weight loss program. Do not follow a ketogenic diet (a high-fat, low-carbohydrate diet used to control seizures) or any other high-fat, low-carbohydrate diet, such as the Atkins diet, while you are taking this medication.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is less than 6 hours before you are scheduled to take your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Topamax (topiramate) may cause other side effects. Tell your doctor if any of these symptoms are severe or do not go away:

numbness, burning, or tingling in the hands or feet

slowed reactions

difficulty concentrating

speech problems, especially difficulty thinking of specific words

memory problems

lack of coordination

confusion

nervousness

aggressive behavior

irritability

mood swings

depression

headache

drowsiness

weakness

excessive movement

uncontrollable shaking of a part of the body

uncontrollable eye movements

extreme thirst

weight loss

constipation

diarrhea

gas

heartburn

change in ability to taste food

swelling of the tongue

overgrowth of the gums

dry mouth

increased saliva

trouble swallowing

nosebleed

teary or dry eyes

back, muscle, or bone pain

missed menstrual periods

excessive menstrual bleeding

skin problems or changes in skin color

dandruff

hair loss

growth of hair in unusual places

ringing in the ears

difficulty falling or staying asleep

swelling of the hands, arms, feet, ankles, or lower legs

difficulty urinating or pain when urinating

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

blurred vision

double vision

eye pain

worsening of seizures

slow heart rate

pounding or irregular heartbeat

chest pain

trouble breathing

fast, shallow breathing

inability to respond to things around you

excessive tiredness

nausea

vomiting

stomach pain

loss of appetite

intense back or side pain

bloody, cloudy, or foul-smelling urine

constant need to urinate

fever

chills

Topamax (topiramate) may cause osteoporosis (a condition in which bones can break more easily) in adults and rickets (abnormal, curved bone growth) in children. Topamax (topiramate) may also slow the growth of children and may decrease the final height that children reach. Talk to your doctor about the risks of taking Topamax (topiramate).

Topamax (topiramate) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Tablets should be stored at room temperature and away from excess heat and moisture (not in the bathroom). Sprinkle capsules should be stored at or below 77°F (25°C). Never store broken tablets or mixtures of sprinkles and soft food. These should be used right away or discarded. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

seizures

drowsiness

speech problems

blurred vision

double vision

trouble thinking

tiredness

loss of coordination

loss of consciousness

dizziness

stomach pain

vomiting

agitation

depression

loss of appetite

pounding or irregular heartbeat

fast, shallow breathing

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Topamax (topiramate).

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.